Safety Science Analyst (Contract – 6 months)-Bangalore India
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties*.
Perform case intake and triage of the incoming safety information or reports from various sources either spontaneously or from a clinical trial
Assist with processing of the adverse events, including but not limited to:
Data entry of safety data onto adverse event tracking systems
Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable)
Assist in the listedness assessment against appropriate label (for Marketed products, if applicable)
Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed
Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Company project personnel, as required within the agreed timelines
Assist with processing and submission of expedited and periodic reports to worldwide regulatory agencies or other recipients (Clients, Regulatory Authorities, Ethics Committees, investigators and company project personnel etc), and prioritize the reports for processing and submission within the regulatory and/or study specific applicable timelines
B Pharma/ M Pharma
We require fresh graduates and post graduates who are available to join immediately
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit http://www.fortrea.com.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.